NICE technology appraisal guidance [TA254]
Published date:
April 2012

NICE has been asked to clarify whether the recommendation for the use of fingolimod extends to people with relapsing remitting multiple sclerosis who are currently receiving treatment with glatiramer acetate, and who experience an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year. NICE understands that this query refers to the note included in the ‘Posology and method of administration’ section of the summary of product characteristics for fingolimod that states that ‘patients can switch directly from beta interferon or glatiramer acetate to fingolimod provided there are no signs of relevant treatment–related abnormalities’. In line with the referral received from the Department of Health, NICE appraised fingolimod with reference to the therapeutic indication specified in the marketing authorisation; that is ‘Patients with high disease activity despite treatment with a beta-interferon’. The manufacturer provided no submission for the other population in the marketing authorisation. Considering that NICE cannot produce guidance for a medicine outside of the licensed indication included in the marketing authorisation, the recommendation for the use fingolimod does not extend to people currently receiving glatiramer acetate.

you've had beta interferon treatment for the past year but you’ve still had as many or more relapses than the year before, or your relapses have continued to be severe.

Why has NICE said this?

NICE looks at how well treatments work, and also at how well they work in relation to how much they cost the NHS. NICE recommended fingolimod because it is a valuable new oral treatment for patients with multiple sclerosis. Although it costs more than other treatments available on the NHS, this was justified by the benefits offered.